Mylan expands EpiPen recall to the U.S.

EpiPen two pack (CBS News)

(CBS Miami) – A recall of the emergency anti-allergy medicine EpiPen is expanding to the U.S. and other markets in North America, Europe, Asia and South America because the allergy shots may not work.

The notice issued Friday by Mylan N.V. expands upon warnings made earlier this month after two reports of the device failing. According to the company, some of the devices may have a defective part that does not allow for the activation of the injector in case of allergic reaction.

Mylan didn’t immediately respond to a question about how many devices are affected by the recall. The U.S. Food and Drug Administration says the recall covers 13 lots distributed from December 2015 through July 2016.

The problems could be potentially life-threatening, although Mylan described the incidence of the defects as “extremely rare.”

The EpiPen is used to treat allergic reactions to certain food and bug bites.

The products can be replaced at no charge by calling 877-650-3494 or emailing customer.service@mylan.com.

The 0.15-mg EpiPen Jr auto-injectors affected by the U.S. recall are:

  • Lot 5GN767, with expiration date of April 2017
  • Lot 5GN773, with expiration date of April 2017
  • Lot 6GN215, with expiration date of September 2017

The 0.3-mg EpiPen auto-injectors affected by the U.S. recall are:

  • Lot 5GM631, with expiration date of April 2017
  • Lot 5GM640, with expiration date of May 2017
  • Lot 6GM082, with expiration date of September 2017
  • Lot 6GM072, with expiration date of September 2017
  • Lot 6GM081, with expiration date of September 2017
  • Lot 6GM088, with expiration date of October 2017
  • Lot 6GM199, with expiration date of October 2017
  • Lot 6GM091, with expiration date of October 2017
  • Lot 6GM198, with expiration date of October 2017
  • Lot 6GM087, with expiration date of October 2017

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